Kornimate/medical-research-clean huggingface dataset:
prediction of venous thrombosis after fracture operation: comparative analysis of different fracture sites

Conditions: Fractures

Summary: the goal of this observational study is to analyze the clinical characteristics of patients who develop lower limb deep vein thrombosis (dvt) following fracture surgery, with a focus on comparing different fracture sites. the main question it aims to answer is: how do the clinical characteristics of postoperative dvt vary across different fracture sites? the study will involve 429 patients who have been diagnosed with postoperative lower limb dvt following fracture surgery. data will be collected on patient demographics, fracture type, surgical approach, thrombus size, number, location, and the occurrence of complications such as pulmonary embolism (pe). participants will also be evaluated for relevant laboratory markers and clinical factors, including coagulation parameters and inflammatory markers. by examining how these factors differ across fracture sites and their relationship to thrombus characteristics, this study seeks to better understand the risk factors and clinical course of postoperative dvt in orthopedic patients. the findings will provide valuable insights for improving patient management strategies and reducing the risk of complications such as pe in those undergoing fracture surgery.


Eligibility criteria:
inclusion criteria: * (1) age requirement: ≥18 years old, gender is not limited. (2) including but not limited to rib fracture, femur fracture, tibia and fibula fracture, ankle fracture and other types of fracture (3) patients with fractures who have undergone surgical treatment and patients with postoperative complications related to venous thrombosis. (3) the patient's clinical data (such as age, gender, fracture type, surgical method, postoperative recovery, etc.) and laboratory data (such as d-dimer, coagulation function, etc.) should be fully available. (4) informed consent: patients voluntarily participate in this study, sign informed consent, and promise to cooperate with the completion of the evaluation and follow-up in the study. (5) patients with diabetes, hypertension and other comorbidities should be recorded, because these diseases may affect the occurrence of venous thrombosis. exclusion criteria: * (1) patients with non-fracture types such as upper limb fracture and spinal fracture are not included. (2) acute patients with symptoms of venous thrombosis such as deep vein thrombosis or pulmonary embolism, or patients with a history of significant thrombosis. (3) patients whose clinical data or laboratory data are incomplete, resulting in no effective analysis. (4) patients currently participating in other clinical trials or interventions. (5) fracture patients who did not receive surgical treatment or only received conservative treatment.
a study of rbt-3 in healthy volunteers and volunteers with stage 3/4 chronic kidney disease

Conditions: Healthy Volunteers; Chronic Kidney Disease

Summary: this is a phase 1b, single center, dose-escalating study evaluating the safety, tolerability, and pharmacodynamic effect of rbt-3 in healthy volunteers and in subjects with stage 3-4 chronic kidney disease.


Eligibility criteria:
inclusion criteria: 1. male and female subjects age 18 to 80 years (inclusive, at time of icf). 2. body weight \<125 kg. 3. able and willing to comply with all study procedures. 4. female subjects must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from screening until 8 days after study drug administration. male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until 8 days after study drug administration. all fertile men with female partners of childbearing potential should be instructed to contact the investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation. 5. ckd as determined by estimated glomerular filtration rate (egfr) between 15-59 ml/min as estimated using the ckd-epi equation (ckd class 3-4). exclusion criteria: 1. history of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers. 2. use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer. 3. serum ferritin \> 500 ng/ml or who have received iv iron within 28 days of screening. 4. women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study. 5. any significant acute or chronic diseases, excluding ckd (egfr ≥15 ml/min). 6. regular use of drugs of abuse and/or positive findings on urinary drug screening. 7. current tobacco use and/or positive findings on urinary cotinine screening. 8. subjects who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects' tasks associated with the protocol. 9. presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated. 10. known hypersensitivity or previous anaphylaxis to fes.
pregabalin for post-craniotomy pain control

Conditions: To Assess the Beneficial Preemptive and Preventive Effects of PGL on the Immediate and Late (1- and 3 Months) Postoperative Analgesia Requirements

Summary: background: proper pain relief is a major concern of patients worldwide. preoperatively, one of the most common questions asked by patients pertains to the amount of pain they will experience after surgery how long it will last and how good will it be controlled. pain concerns the surgical team as well, because of its correlation with clinical outcomes and patients' satisfaction rate. studies have shown that negative clinical outcome with regard to pain control includes decreases in vital capacity and alveolar ventilation, pneumonia, tachycardia, hypertension, myocardial ischemia, transition into chronic pain, poor wound healing, and psychological sequelae . pain has been found to be one of the three most common medical causes of delayed/aborted discharge after ambulatory surgery, the other two being drowsiness and postoperative nausea/vomiting. despite progress that has been made with regard to postoperative pain control, and the development of new standards for pain control, many patients continue to experience intense pain after surgery . recent advances in the understanding of the particularities of central sensitization indicate that it plays an important role in post surgical and post traumatic pain and therefore should be avoided

hypothesis: no studies considered the comparison of pre-emptive and post-incisional or post-surgery pgl administration. the investigators hypothesize that the administration of pgl preemptively would diminish pain sensation, and therefore the need for pain administration in neurosurgical patients, better than postoperatively. in addition, preoperative administration could reduce the level of anxiety in these patients. it should be stressed that this study will used a placebo controlled group and at availuating placebo related psychological effective treatment versus a central efficacy of lyrica objectives: to assess the beneficial preemptive and preventive effects of pgl on the immediate and late (1- and 3 months) postoperative analgesia requirements and pain scores in neurosurgical patients.

Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiologists) physical status i-iii * patients who will undergo intracranial surgery under general anesthesia only * patients undergoing awake-technique procedures will also be enrolled. exclusion criteria: * allergy to opioids, midazolam, pgl, or non-steroidal anti-inflammatory drugs (nsaids), dipyrone * history of chronic pain or psychiatric disorders and the use of centrally acting antidepressant and antipsychotic drugs. patients longtime users of sedatives, or antiepileptics * soldiers and pregnant women * emergency cases, dbs procedures and patients unable to comprehend and sign the consent form
adipocytokines and polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: inflammation may play a role in the development of polycystic ovary syndrome (pcos). in this study, the investigators investigated the expression of different mediators of inflammation in fatty tissue and in blood in women with and without pcos.


Eligibility criteria:
inclusion criteria: * women with pcos were included according to the rotterdam diagnostic criteria for pcos. control women met none of the criteria for pcos exclusion criteria: * oc´s within the last three months, or other medication known to alter glucose/insulin metabolism * other known chronic diseases

Keywords: the independent effect of pcos and obesity on adipose expression and plasma levels of adipocytokines
moisturizer to prevent atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: atopic dermatitis (ad) is a chronic, relapsing inflammatory skin disorder associated with a decreased ability of the skin to function as an efficient immunological barrier. the disease is now two to three times more prevalent in children than it was just four decades ago. it is manifested by eczematous skin lesions associated with severe itch, leading to a significant impairment in quality of life. of additional importance, ad oftentimes progresses to allergic rhinitis and/or asthma, a process referred to as the "atopic march." recent reports have indicated that daily application of moisturizing creams on neonates and infants can prevent the occurrence of ad and subsequently food allergies. this is postulated to be the outcome of restoring the barrier integrity of the skin through the daily application of moisturizer.


Eligibility criteria:
inclusion criteria: 1. a healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment \& less than 120 hours prior to enrollment 2. average forearm tewl reading of \>8.50 g/m2 3. mothers must be aged \>18 years 4. parents' ability to complete questionnaire(s) at defined times throughout study duration 5. parents or legal guardian provide informed written consent exclusion criteria: 1. preterm birth (birth prior to 37 weeks gestation) 2. neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days 3. neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult 4. neonate has been administered oral or parenteral antibiotics from birth until study enrollment 5. neonate has a serious health issue which, at parent or investigator discretion, would make it difficult for the neonate or parents to take part in the trial 6. any conditions which precludes the daily application of moisturizing lotion 7. any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
renal hemodynamic effects of rlx030a in subjects with chronic heart failure (chf)

Conditions: Chronic Heart Failure (CHF)

Summary: this study will assess the renal hemodynamic effect of rlx030 infusion in subjects with chronic heart failure. in addition safety and effects on renal function and biomarkers will be assessed.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed. * male and female heart failure patients with body weight \<160 kg, on standard therapy including a stable dose of furosemide 40-240 mg/day orally (p.o). or equivalent dose of loop diuretics, reduced systolic function (lvef ≤ 45% measured within the past 6 months), bnp ≥ 100 pg/ml or nt-pro-bnp of ≥ 400 pg/mlnyha class ii or iii, and worsening symptoms, e.g. fatigue, dyspnea, breathlessness within 3 months * mild to moderate renal impairment exclusion criteria: * systolic blood pressure (sbp) \< 110 mm hg at the time of randomization * administration of intravenous radiographic contrast agent within 72 hours prior to randomization or acute contrast-induced nephropathy at the time of randomization * current use of non-steroidal antiinflammatory drugs (nsaids) * current or planned (through the completion of study drug infusion) treatment with any i.v. therapies, including vasodilators (including nesiritide), positive inotropic agents, vasopressors, levosimendan, or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device). * clinically significant hepatic impairment defined as hepatic encephalopathy of any degree or total bilirubin \> 50 μmol/l (3 mg/dl) or, if patient is not on warfarin therapy, inr \> 2.0 (or prothrombin time \> 2 \* uln) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: heart failure rlx030 hemodynamics cardiovascular diseases
denosumab plus enzalutamide, abiraterone and prednisone compared to denosumab plus enzalutamide alone for men with castrate resistant prostate cancer (crpc) with bone metastases

Conditions: Prostate Cancer

Summary: this is a correlative study to characterize serum metabolites associated with bone deposition, growth and turnover in patients with newly diagnosed metastatic crpc who are not currently receiving bone targeting agents.


Eligibility criteria:
inclusion criteria: * histologic proof of adenocarcinoma of the prostate with clinical evidence of metastatic disease to the bone. * castrate resistant progression of prostate carcinoma, as shown by: * serum testosterone level \<50 ng/dl or prior bilateral orchiectomy. treatment to maintain castrate levels of testosterone should continue, and * either symptomatic progression, or, if patient is asymptomatic then a rising serum psa in two occasions at least 1 week apart, with minimum pre-treatment serum psa of 5 ng/dl. * patients with nodal disease are eligible. * bi-dimensionally measurable disease within the bone. * life expectancy of at least 12 weeks. * ecog performance status \< 2 * adequate: * bone marrow function; absolute neutrophil count \> 1,500 mm3, platelet count of \> 100,000 mm3 and hemoglobin \> 9.0 gm/dl. * hepatic function; sgot/sgpt and conjugated bilirubin less than twice the upper limit of normal. * renal function; serum creatinine ≤ 2 mg/dl (or, if creatinine \> 2 mg/dl, then a creatinine clearance of at least 35 ml/min (measured or estimated by the cockroft formula: clcr = \[(140-age) x wt (kg)\]/\[72 x serum creatinine (mg/dl)\]. * no evidence of coagulopathy as indicated by pt \< 1.5x upper limit of normal. * serum calcium (corrected) from 8 to11.5 mg/dl (2 to 2.9 mmol/l) - patients must sign an informed consent indicating that they are aware of the investigational nature of the study. exclusion criteria: * patients with variant histologies (e.g., ductal or small cell carcinoma). * patients with visceral disease are ineligible. * patients who have had prior sipuleucel-t, docetaxel, cabazitaxel, abiraterone or enzalutamide as a single agent, or in combination therapy. * concurrent cancer chemotherapy, radiotherapy or surgery. * concurrent serious infection. * life threatening illness (e.g., congestive heart failure, uncontrolled angina or myocardial infarction in the prior six months). * hypertension uncontrolled by medication. * patients who are known to require invasive dental procedures. * no known or suspected brain metastases (note: patients with treated epidural disease are allowed) * administration of any investigational drug within 28 days prior to receipt of denosumab. * age ≤ 18 years of age

Keywords: castrate-resistant prostate cancer with bone metastases
field administration of stroke therapy - magnesium (fast-mag) trial

Conditions: Cerebrovascular Accident

Summary: the goal of this study is to evaluate the effectiveness and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke.

stroke is the third leading cause of death and the leading cause of adult disability in the united states. each year, more than 750,000 americans suffer a symptomatic stroke. currently, tissue plasminogen activator (rt-pa) is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. in addition, rt-pa cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage. the purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. this study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. this trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.

Eligibility criteria:
inclusion criteria: * suspected stroke identified by the los angeles prehospital stroke screen * age 40-95, inclusive * last known well time within 2 hours of treatment initiation * deficit present for \>/= 15 minutes exclusion criteria: * coma * rapidly improving neurologic deficit * pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations * systolic blood pressure (sbp) \ 220 * known severe renal dysfunction (on dialysis or known chronic creatinine \> 3.0) * severe respiratory distress (o2 sat \ /= 24) * known second or third degree heart block with no pacemaker in place * major head trauma in the last 24 hours * recent stroke within prior 30 days * patient unable to give informed consent and no available on scene consent or assent provider

Keywords: stroke brain attack magnesium sulfate neuroprotection prehospital care emergency medical services
modafinil in opioid induced sedation

Conditions: Cancer; Pain

Summary: * the primary objective of this study is to evaluate the efficacy of modafinil in the treatment of opioid induced sedation as measured by the epworth sleepiness scale (ess). * the secondary objective is to estimate the frequency and severity of toxicity associated with modafinil (400mg) in patients with opioid induced sedation.

sedation is a common side effect of opioid analgesics. in patients where this remains a dose limiting toxicity, stimulants (caffeine, methylphenidate, ephedrine, amphetamine) have been the primary class of agents used to counteract sedation. modafinil is a novel stimulant that is fda approved for the treatment of narcolepsy and has a very different side effect profile than traditional stimulants. the potential role of this agent in the treatment of opioid induced sedation remains undefined. this study, which utilizes a prospective, randomized, blinded, cross-over design, will collect daily information on sedation (epworth sleepiness scale), pain, opioid consumption, and adverse effects in 90 patients suffering from opioid induced sedation within the johns hopkins medical institutions.

Eligibility criteria:
inclusion criteria: * epworth sleepiness scale \> 10 * etiology of sleepiness is attributed only to opioids * patient must have been taking an opioid for more than 2 weeks or have been on a non-escalating dose of opioids for at least 1 week * patient must be able to give written informed consent * age \>18 years exclusion criteria: * hypersensitivity to modafinil * mini-mental status exam (mmse) \< 25/30 * renal impairment (calculated creatinine clearance \< 40) * hepatic dysfunction (total bilirubin \> 1.8, ast \> 75iu/l, alt \> 100iu/l, prothrombin time \> 40% * known history of cardiovascular disease (i.e., left ventricular hypertrophy, ischemic ecg changes, chest pain, arrhythmia, mitral valve prolapse, recent myocardial infarction, unstable angina, uncontrolled hypertension) * woman who are pregnant, breast-feeding or on hormonal contraception * patients taking tricyclic antidepressants, cns stimulants, hormonal contraceptives or drugs that are inhibitors or inducers of cyp 3a4

Keywords: sedation pain modafinil opioids
molecular imaging to capture disease heterogeneity in acute myeloid leukemia

Conditions: Leukemia, Myeloid, Acute

Summary: the current understanding of acute myeloid leukemia (aml) is that one site of bone marrow (bm) sampling serves as a window that represents all aml cells distributed throughout the bm, an assumption that has yet to be questioned. simulation in mice led to inconsistent representation of the full bm, which can incorrectly suggest the absence of leukemic cells. positron-emission tomography (pet) scan can detect areas of high metabolic activity in the body using for instance a radioactive sugar. in one report, its use in human aml has provided proof-of-principle evidence of unequal distribution of aml cells in bm. accordingly, the alternative hypothesis is to test if pet scan can demonstrate if bm geography can alter aml cells spread and home them as distinct areas rather than uniform spread as if they are distributed in liquid state.


Eligibility criteria:
inclusion criteria: * new diagnosis of aml according to the who (world health organization) criteria exclusion criteria: * prior malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease. * acute promyelocytic leukemia (apl). * ecog (eastern cooperative oncology group) performance status of 3 or more * inadequate renal function (i.e., estimated gfr (glomerular filtration rate) \< 60 ml/min/1.73m2). * inadequate hepatic function (i.e., serum bilirubin \> 1.5×uln; ast (aspartate aminotransferase), alt (alanine aminotransferase) and alp (alkaline phosphatase) \> 2.5×uln) * presence of uncontrolled systemic fungal, bacterial, viral or other infections (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment). * having any other severe concurrent disease or serious organ dysfunction that may place the patient at undue risk to receive induction therapy. * pregnancy or lactating female.

Keywords: acute myeloid leukemia pet/ct scan